Cervical Disc Degenerative Disorder
Conditions
Keywords
Cellentra ACDF
Brief summary
The purpose of this study is to assess the clinical and radiographic outcomes in patients who undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft spacers, and the MaxAn® Anterior Cervical Plate System. Cellentra VCBM will be compared to published data for autograft in NDI (Neck Disability Index) improvement and radiographic success of fusion.
Detailed description
This is a prospective single-arm multi-center study of Cellentra Viable Cell Bone Matrix (VCBM) and the MaxAn® Anterior Cervical Plate System when used in anterior cervical discectomy and fusion procedures. This study will enroll up to eighty (80) subjects across up to eight (8) clinical sites. Subjects will be recruited from a pool of patients presenting to investigators for an anterior cervical discectomy and fusion procedure.
Interventions
BIOLOGICALCellentra VCBM
Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
Sponsors
Zimmer Biomet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is scheduled to undergo a two or three level primary spinal fusion surgery between the levels of C2-T1 (Cervical 2 to Thoracic 1) using Cellentra™ VCBM, allograft spacers, and the MaxAn® Anterior Cervical Plate System. * The subject is 18 years of age or older. * The subject was unresponsive to conservative treatment for at least 6 weeks unless clinically indicated sooner. * The subject has persistent neck, shoulder, or arm pain consistent with cervical degenerative disc disease confirmed by patient history and radiographic studies. * The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
Exclusion criteria
1. Subject has an active local or systemic infection. 2. Subject is morbidly obese, defined as a BMI greater than 40. 3. Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up. 4. Subject has inadequate tissue coverage over the operative site. 5. Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, osteopenia, osteomalacia and/or osteoporosis. 6. Any previous cervical spinal surgery. 7. Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.) or immunocompromised. 8. Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study. 9. Subject who does not meet the specific indications for use of the Cellentra™ VCBM or MaxAn® Anterior Cervical Plate System. 10. Subject is pregnant, lactating or interested in becoming pregnant during the duration of the study. 11. Subject is currently involved in another investigational drug or device study that could confound study data. 12. Subject is a prisoner. 13. Subject has a metal sensitivity/foreign body sensitivity. 14. Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain. 15. Subject has sensitivity or allergies to any of the processing agents. (See package insert for Cellentra™ VCBM).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in NDI From Baseline | 12 months after device implantation | Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each of the 10 items is scored from 0 - 5, with a maximum score of 50. The obtained score is multiplied by 2 to produce a percentage score. A higher score indicates more patient-rated disability (0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation). The minimal clinically important difference or change (MCID / MCIC) is described as the smallest difference or change that patients perceive as beneficial. In patients with cervical radiculopathy the MCID is 7 points of change ( 14%). In order to demonstrate improvement in status, the NDI would need to be reduced by at least 14%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Radiographic Success at 24 Months | 24 Months | Radiographic fusion was assessed at each operated level using the Bridwell fusion grading system: * Grade I (definite) - Fused with remodeling and trabeculae * Grade II (probable) - Graft intact, not fully remodeled and incorporated through, no lucencies * Grade III (probably not) - Graft intact, but definite lucency at the top or bottom of the graft * Grade IV (no) - Definitely not fused, with resorption of bone graft or collapse. Radiographic success was defined as grade 1 or 2 fusion at every operated level at 24 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cellentra VCBM Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects. | 81 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Cellentra VCBM |
|---|---|
| Age, Continuous | 53.9 years STANDARD_DEVIATION 9.5 |
| BMI (kg/m^2) | 30.4 kg/m^2 STANDARD_DEVIATION 5.4 |
| Previous Spine Surgery | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 72 Participants |
| Region of Enrollment United States | 81 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 36 Participants |
| Tobacco Use Current | 31 Participants |
| Tobacco Use Never | 38 Participants |
| Tobacco Use Past | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 81 |
| other Total, other adverse events | 43 / 81 |
| serious Total, serious adverse events | 8 / 81 |
Outcome results
Primary
Change in NDI From Baseline
Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each of the 10 items is scored from 0 - 5, with a maximum score of 50. The obtained score is multiplied by 2 to produce a percentage score. A higher score indicates more patient-rated disability (0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation). The minimal clinically important difference or change (MCID / MCIC) is described as the smallest difference or change that patients perceive as beneficial. In patients with cervical radiculopathy the MCID is 7 points of change ( 14%). In order to demonstrate improvement in status, the NDI would need to be reduced by at least 14%.
Time frame: 12 months after device implantation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cellentra VCBM | Change in NDI From Baseline | Baseline | 52.1 score on a scale | Standard Deviation 19.1 |
| Cellentra VCBM | Change in NDI From Baseline | 12 months | 28.5 score on a scale | Standard Deviation 24.3 |
| Cellentra VCBM | Change in NDI From Baseline | Mean Change in NDI | 24.0 score on a scale | Standard Deviation 21.9 |
Secondary
Number of Participants With Radiographic Success at 24 Months
Radiographic fusion was assessed at each operated level using the Bridwell fusion grading system: * Grade I (definite) - Fused with remodeling and trabeculae * Grade II (probable) - Graft intact, not fully remodeled and incorporated through, no lucencies * Grade III (probably not) - Graft intact, but definite lucency at the top or bottom of the graft * Grade IV (no) - Definitely not fused, with resorption of bone graft or collapse. Radiographic success was defined as grade 1 or 2 fusion at every operated level at 24 months
Time frame: 24 Months
Population: 71/81 of originally enrolled participants had radiographs available for analysis at 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cellentra VCBM | Number of Participants With Radiographic Success at 24 Months | 35 Participants |